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Report for Clinical Trial NCT02770014

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer

Patient with Non-Small Cell Lung Cancer (NSCLC) that might have a genetic change (mutation) in the Epidermal Growth Factor Receptor (EGFR) are invited to take part in this study. This research study is evaluating a new blood test that is capable of detecting an EGFR mutation in cancer without a biopsy.

NCT02770014 Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer
MeSH:Lung Neopla Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Erlotinib

Type: Drug
Group Labels: 1

EGFR mutation Positive, Treatment With Erlotinib

Primary Outcomes

Description: Number of participants who were alive with evidence of complete or partial response, evaluated using RECIST 1.1 criteria. Patients that underwent rapid plasma genotyping and had an EGFR mutation and who were treated with erlotinib were included in this calculation.

Measure: Overall Response Rate

Time: From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation.

Secondary Outcomes

Description: The turnaround time from study registration to treatment initiation was recorded for the plasma genotyping strategy versus standard tumor genotyping. For rapid plasma genotyping, turnaround time is the time between ordering plasma genotyping and obtaining results; this time period was compared to the turnaround time of obtaining the tumor genotyping results.

Measure: Turnaround Time

Time: Maximum 38 days

Description: Concordance between results of plasma genotyping and tumor genotyping, among patients with tissue available for standard genotyping

Measure: Positive Predictive Value (PPV) And False Negative Rate Of Plasma Genotyping

Time: PPV and False Negative Rate can be assessed when plasma and tissue results are available for each patient; average plasma result turnaround time was 4 days, versus average of 20 days for tissue result turnaround time.

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 L858R

Biopsy requirement may be waived if not technically feasible and plasma genotyping reveals an eligible EGFR mutation (exon 19 del/L858R). --- L858R ---

HPO Nodes